Compression Therapy for Swelling Management Following Ankle Injury

NCT06772649 | Not Yet Recruiting Phase 4

• 1 other identifier: BSWELL-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

After an injury or undergoing foot/ankle surgery, patients often experience swelling in the injured area. Under current standard of care, plaster casts are removed at six weeks and patients are put in a walking boot. At this point in time of their recovery, patients are permitted to weight bear and move in their walking boot without other help, like crutches. This has shown to cause a significant amount of swelling in the ankle and foot between week six and twenty-six post-injury/surgery. There is not much research that has looked at the effects of compression on reducing swelling in post-operative and non-operative ankle fracture, mid-foot, hindfoot, or ankle arthrodesis. This research is important because post-injury swelling can lead to wound complications and limit functionality. Therefore, finding new ways to reduce swelling could help prevent future complications. The purpose of this study is to see if the Bauerfeind ankle compression sleeve is a safe post-operative/injury foot and ankle swelling management tool. Use of a compression sleeve will be compared to just using a walking boot, which is current standard of care, to determine if the compression sleeve reduces post-operative/injury foot and ankle swelling. The study will follow patients improvement in swelling and pain. The compression sleeve will also be assessed for product safety. Safety is determined by watching the frequency, severity and seriousness of any side effects or complications, known as adverse events, that may be experienced while in the study. The Bauerfeind ankle compression sleeve has been and is currently used in humans as a swelling reducing devise in the foot and ankle but has not been studied in a randomized control trial.

Conditions

Ankle Fracture; Ankle Arthrodesis

Keywords

non-operative ankle fracture management; operative ankle fracture management; ankle arthrodesis; mid-foot arthrodesis; hind-foot arthrodesis

Outcome Measures

Primary Outcomes (1)

• Swelling (volume)

  Ankle swelling will be measured using a standard volume displacement test. Patients will place their foot in a tub of water of known volume, and the displaced volume will be measured. This procedure will be completed for both ankles.

  6 weeks, 12 weeks, and 24 weeks post-injury/post-operative

Secondary Outcomes (2)

• Visual Analog Scale for Pain

  6 weeks, 12 weeks, and 24 weeks post-injury/post-operative

• Product-Related Safety

  6 weeks, 12 weeks, and 24 weeks post-injury/post-operative

Study Arms (2)

Bauerfeind Ankle Compression Sleeve

EXPERIMENTAL

Patients in this arm will be fitted for a Bauerfeind ankle compression sleeve at 6 weeks post-injury/post-operative following the removal of their walking boot. Patients will use the compression sleeve until 6 months post-injury/post-operative.

Other: Compression sleeve

Control

NO INTERVENTION

Patients in the control group will wear a walking boot until 6 weeks post-injury/post-operative. Upon removal of the boot, no swelling aid will be provided to patients (as per standard of care)

Interventions

Compression sleeve OTHER

The Bauerfeind compression sleeve is a fabric sleeve designed to support the ankle during movement. It's made of a compressive knit material that increases sensorimotor feedback, enhances blood circulation, and stimulates metabolism. The design helps reduce ligament strain, activates the foot's stabilizing muscles more quickly, and improves joint coordination.

Also known as: Bauerfeind ankle compression sleeve

Bauerfeind Ankle Compression Sleeve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing outpatient ankle, mid-foot or hindfoot arthrodesis, fracture surgery, or non-operative ankle fracture management at the Queen Elizabeth II Health Sciences Center.
• Aged 18 or over

You may not qualify if:

• Patients undergoing other ankle procedures
• Patients who have any signs of wound healing complications post-surgery
• Patients who are unable to progress to walking boot and weight-bearing management at 6 weeks post operation/injury.
• Patients with other co-morbidities that may create bias within the results (lymphedema, heart conditions etc.)
• Patients who are unable to speak and read English, and/or in the opinion of the Principal Investigator are unable to provide fully informed consent.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Bauerfeind: collaborator

Study Sites (1)

Queen Elizabeth II Health Science Center

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Central Study Contacts

Devan Pancura, MSc

CONTACT

(902)473-7137; Devan.Pancura@nshealth.ca

Mark Glazebrook, PhD, MD

CONTACT

(902)473-7137; markglazebr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)